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Carbamazepine (Carbamazepine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Carbamazepine and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (1094)
Death (229)
Life Threatening Events (53)
Disability (29)

Reports by Reaction Type

Convulsion (145)Completed Suicide (137)Toxicity To Various Agents (76)Pyrexia (60)Maternal Exposure During Pregnancy (58)Drug Interaction (56)Fatigue (55)Drug Rash With Eosinophilia and Systemic Symptoms (53)Stevens-Johnson Syndrome (52)Foetal Exposure During Pregnancy (51)Drug Ineffective (49)Epilepsy (49)

Below are a few examples of reports where side effects / adverse reactions may be related to Carbamazepine. For a complete list or a specific selection of reports, please use the links above.

Possible Carbamazepine side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-27

Patient: 54 year old male

Reactions: General Physical Condition Abnormal, Perivascular Dermatitis, Cytolytic Hepatitis, Rash, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Lymphocytic Infiltration, Eosinophilia, Myalgia, Skin Lesion, Dermatitis Exfoliative, Rash Maculo-Papular, Leukocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Indication: Neuropathy Peripheral

Cilostazol
    Indication: Antiplatelet Therapy

Other drugs received by patient: Aspirin; Clopidegrel



Possible Carbamazepine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Carbamazepine

Other drugs received by patient: Keppra



Possible Carbamazepine side effects in 53 year old female

Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-08-24

Patient: 53 year old female

Reactions: Heart Valve Incompetence, Nodal Rhythm, Sinus Bradycardia, Tremor, Atrioventricular Block Second Degree, Fatigue, Left Atrial Dilatation, Cardiac Hypertrophy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Dosage: 200 mg, qd

Lithium Carbonate
    Dosage: 250 mg, bid

Quetiapine
    Dosage: 200 mg, qd

Other drugs received by patient: Levothyroxine Sodium; Atorvastatin; Cinolazepam



Possible Carbamazepine side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Convulsion

Drug(s) suspected as cause:
Carbamazepine



Possible Carbamazepine side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Hyponatraemia, Pyrexia, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Indication: Product Used FOR Unknown Indication

Rebif
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01



Possible Carbamazepine side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Convulsion

Drug(s) suspected as cause:
Carbamazepine



Possible Carbamazepine side effects in female

Reported by a physician from Canada on 2012-08-23

Patient: female, weighing 79.4 kg (174.7 pounds)

Reactions: Sick Sinus Syndrome, Device Related Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Afinitor
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Carbamazepine
    Dosage: 200 mg, tid
    Indication: Convulsion
    Start date: 2001-01-01

Cymbalta
    Dosage: unk
    Indication: Depression
    Start date: 2012-02-10

Insulin
    Dosage: 20 uam 4 upm
    Indication: Diabetes Mellitus
    Start date: 2006-10-01

Levothyroxine Sodium
    Dosage: 150 mg qpm
    Indication: Hypothyroidism
    Start date: 2008-01-01

Lipitor
    Indication: Hypertriglyceridaemia

Lipitor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2001-01-01

Placebo
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Placebo
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Trazodone Hydrochloride
    Dosage: 100 mg, qhs
    Indication: Depression
    Start date: 2008-01-01

Wellbutrin
    Dosage: 150 mg qpm
    Indication: Depression
    Start date: 2008-01-01



Possible Carbamazepine side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-22

Patient: 38 year old female

Reactions: Overdose, Ventricular Fibrillation, Intentional Self-Injury, Altered State of Consciousness, Cardiac Arrest

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Dosage: 30 g
    Administration route: Oral

Maprotiline Hydrochloride
    Dosage: 2.1 g
    Administration route: Oral
    Indication: Depression



Possible Carbamazepine side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22

Patient: 36 year old female

Reactions: Thrombosis, Abdominal Pain Lower, Drug Ineffective, Maternal Exposure During Pregnancy, Ruptured Ectopic Pregnancy, Drug Interaction, Vaginal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Other drugs received by patient possibly interacting with the suspect drug:
Implanon
    Indication: Contraception



Possible Carbamazepine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Migraine, Overdose, Malaise, Drug Ineffective, Intraocular Pressure Increased, Depression, Drug Level Decreased, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Keppra
    Dosage: 1000 mg, unk
    Indication: Migraine

Keppra
    Dosage: 200 mg, unk

Tegretol-XR
    Dosage: 1200 mg, unk

Tegretol-XR
    Dosage: 1400 mg (200mg 7 times per day)

Other drugs received by patient: Simvastatin



Possible Carbamazepine side effects in 23 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-21

Patient: 23 year old male

Reactions: Spinocerebellar Disorder, Epilepsy

Drug(s) suspected as cause:
Carbamazepine

Other drugs received by patient: Lamotrigine; Levetiracetam; Gabapentin; Lamotrigine; Levetiracetam; Clobazam; Lamotrigine; Lamotrigine; Valproate Sodium



Possible Carbamazepine side effects in 62 year old female

Reported by a physician from Netherlands on 2012-08-21

Patient: 62 year old female

Reactions: Drug Level Below Therapeutic, Potentiating Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Other drugs received by patient possibly interacting with the suspect drug:
Voriconazole
    Dosage: maintenance dose (425mg)

Voriconazole
    Dosage: loading dose for 1 day
    Administration route: Oral
    Indication: Fungal Infection

Voriconazole
    Dosage: maintenance dose
    Administration route: Oral

Voriconazole
    Dosage: loading dose of 6 mg/kg (510mg)

Other drugs received by patient: Amphotericin B



Possible Carbamazepine side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-20

Patient: 47 year old female

Reactions: Chest Discomfort, Middle Insomnia, Tonic Clonic Movements, Status Epilepticus, Complex Partial Seizures

Drug(s) suspected as cause:
Carbamazepine
    Dosage: 800 mg/day

Carbamazepine
    Dosage: unk ukn, unk
    Indication: Complex Partial Seizures

Clobazam
    Indication: Complex Partial Seizures

Topiramate
    Dosage: 150 mg/day
    Indication: Complex Partial Seizures

Other drugs received by patient: Gabapentin



Possible Carbamazepine side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-17

Patient: 50 year old female, weighing 93.0 kg (204.6 pounds)

Reactions: Liver Disorder

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Restless Legs Syndrome
    Start date: 2010-12-01
    End date: 2011-02-28

Femoston
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Menopause
    Start date: 1999-01-01
    End date: 2011-03-04

Ibuprofen
    Dosage: 800 mg, bid
    Administration route: Oral
    Indication: Headache
    Start date: 2001-01-01
    End date: 2011-03-04

Lisinopril
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2006-01-01
    End date: 2011-03-04

Tramadol HCL
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Back Pain
    Start date: 2006-01-01
    End date: 2011-03-04

Other drugs received by patient: Metoprolol Tartrate



Possible Carbamazepine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Nausea, Dizziness, Headache, Transient Ischaemic Attack, Convulsion

Drug(s) suspected as cause:
Carbamazepine

Other drugs received by patient: Coreg



Possible Carbamazepine side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Dyspnoea, Dysphagia, Swelling, Anaphylactic Shock

Drug(s) suspected as cause:
Carbamazepine



Possible Carbamazepine side effects in 20 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 20 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Gabapentin
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Sultiame; Corticotropin; Zonisamide



Possible Carbamazepine side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-16

Patient: 47 year old female

Reactions: Middle Insomnia, Chest Discomfort, Tonic Clonic Movements, Status Epilepticus, Complex Partial Seizures

Drug(s) suspected as cause:
Carbamazepine
    Dosage: 800 mg/day

Carbamazepine
    Dosage: unk ukn, unk
    Indication: Complex Partial Seizures

Clobazam
    Indication: Complex Partial Seizures

Topiramate
    Dosage: 150 mg/day
    Indication: Complex Partial Seizures

Other drugs received by patient: Gabapentin



Possible Carbamazepine side effects in 24 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 24 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Nitrazepam; Corticotropin; Zonisamide; Ethosuximide; Vitamin B6



Possible Carbamazepine side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-16

Patient: 38 year old female

Reactions: Grand MAL Convulsion, Movement Disorder, Aphasia, Unresponsive To Stimuli, Tonic Clonic Movements, Akinesia, Status Epilepticus

Drug(s) suspected as cause:
Carbamazepine
    Dosage: unk ukn, unk

Carbamazepine
    Dosage: 400 mg/day



Possible Carbamazepine side effects in 8 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 8 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Benzodiazepine Derivatives; Corticotropin; Potassium Bromide



Possible Carbamazepine side effects in 17 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 17 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Gabapentin
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Vitamin B6; Corticotropin; Zonisamide; Nitrazepam; Potassium Bromide; Benzodiazepine Derivatives



Possible Carbamazepine side effects in 17 year old female

Reported by a physician from Japan on 2012-08-15

Patient: 17 year old female

Reactions: Depressed Level of Consciousness, Multiple Drug Overdose, Asthenia, Altered State of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lamictal
    Dosage: 1100mg per day
    Administration route: Oral
    End date: 2012-08-09

Lamictal
    Administration route: Oral
    Indication: Epilepsy



Possible Carbamazepine side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-14

Patient: 23 year old female

Reactions: Tubulointerstitial Nephritis

Drug(s) suspected as cause:
Carbamazepine
    Dosage: unk

Diazepam
    Dosage: unk

Lorazepam
    Dosage: unk

Paraldehyde
    Dosage: unk

Phenobarbital TAB
    Dosage: unk

Phenytoin
    Dosage: unk



Possible Carbamazepine side effects in 93 year old male

Reported by a pharmacist from United States on 2012-08-14

Patient: 93 year old male, weighing 55.9 kg (123.0 pounds)

Reactions: Drug Level Above Therapeutic, Hyponatraemia, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine



Possible Carbamazepine side effects in 47 year old female

Reported by a physician from Germany on 2012-08-13

Patient: 47 year old female, weighing 90.0 kg (198.0 pounds)

Reactions: Vomiting, Nausea, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Dosage: 400

Dipiperon
    Dosage: unknown dose

Gabapentin
    Dosage: unknown dose

Keppra
    Dosage: unknown dose



Possible Carbamazepine side effects in 17 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-10

Patient: 17 year old male

Reactions: Intentional Overdose, Suicide Attempt, Toxicity To Various Agents, Flashback, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Other drugs received by patient: Clorazepate Dipotassium; Cloxazolam; Valproate Sodium; Zonisamide; Yokukan-SAN



Possible Carbamazepine side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10

Patient:

Reactions: Tourette's Disorder

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Adenosine
    Indication: Product Used FOR Unknown Indication

AN Unknown Medication
    Indication: Product Used FOR Unknown Indication

Carbamazepine
    Indication: Product Used FOR Unknown Indication

Cefaclor
    Indication: Product Used FOR Unknown Indication

Celiprolol
    Indication: Product Used FOR Unknown Indication

Fluoxetine HCL
    Indication: Product Used FOR Unknown Indication

Fluvoxamine Maleate
    Indication: Product Used FOR Unknown Indication

H1n1 Vaccine
    Indication: Product Used FOR Unknown Indication

Hepatitis B Vaccine
    Indication: Product Used FOR Unknown Indication

Influenza Vaccine
    Indication: Product Used FOR Unknown Indication

Methylphenidate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metoclopramide
    Indication: Product Used FOR Unknown Indication

Mirtazapine
    Indication: Product Used FOR Unknown Indication

Montelukast
    Indication: Product Used FOR Unknown Indication

Moxifloxacin
    Indication: Product Used FOR Unknown Indication

Niaprazine
    Indication: Product Used FOR Unknown Indication

Oxatomide
    Indication: Product Used FOR Unknown Indication

Pregabalin
    Indication: Product Used FOR Unknown Indication

Theophylline
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Indication: Product Used FOR Unknown Indication

Valpromide
    Indication: Product Used FOR Unknown Indication

Venlafaxine
    Indication: Product Used FOR Unknown Indication

Zolmitriptan
    Indication: Product Used FOR Unknown Indication

Zolmitriptan



Possible Carbamazepine side effects in 8 year old male

Reported by a physician from United States on 2012-08-10

Patient: 8 year old male

Reactions: Porphyria Acute, Inappropriate Antidiuretic Hormone Secretion, Hypertension, Post Streptococcal Glomerulonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amoxicillin
    Indication: Otitis Media

Carbamazepine
    Indication: Convulsion

Clobazam
    Indication: Convulsion

Lorazepam
    Indication: Convulsion

Topiramate
    Indication: Convulsion

Valproic Acid
    Indication: Convulsion



Possible Carbamazepine side effects in 8 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 8 year old female

Reactions: Drug Ineffective, Fall, Convulsion

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Corticotropin; Benzodiazepine Derivatives; Potassium Bromide

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